Clinical Trial Therapeutic Monitoring
At KBI our therapeutic monitoring programs are custom tailored to the product & clinical indication leveraging multiple methods.
Aims of a program:
Safety, Acute Affects
- Product engraftment, persistance
- Product related immunological response (cellular, soluble factors)
- To identify marker(s) that predict a patient’s response to therapy
- To identify cell type(s) that are responsible for therapeutic success
By example, methods may include:
- In vitro cellular bioassays (anti-tumor cytotoxicity, product differentiation, expansion, tumor site accumulation)
- Multi-color Flow cytometric analysis (surface, intracellular, cell signaling)
- Cytokine analysis via ELISA, ELISPOT, or Bead-Based Multi-cytokine array
- Cell activation, Cell cycle monitoring, Proliferation, Apoptosis
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